FDA.report

NA

Primary DI
04055207011089
Brand
NA
Company
Richard Wolf GmbH
Model
867794
Catalog number
8677.94
Device description
SCALPEL 11.5FR HOOK-SHAPED for optical urethrotomes, cutting position 6 O'clock, for cutting urethral strictures, reusable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EZOUrethrotome
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
EZOUrethrotomeGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207011089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207011089040552070110894055207011089

GMDN Terms

TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter3.83333333333Millimeter

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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